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Bioavailability, bioequivalence and biowaiver data summary forms

1 April 2020

Summary of a bioavailability or bioequivalence study

This form should be used by prescription medicine, over-the-counter and registered complementary medicines sponsors to submit a summary of a bioavailability or bioequivalence study.

How to access a pdf or Word document

An alternative Bioequivalence Study Information Form is available to summarise each bioequivalence study. For more information, see Bioequivalence data summary templates below.

Bioequivalence data summary templates

The optional bioequivalence data summary templates are designed to help you prepare a submission for a new generic prescription medicine and ensure all the necessary information is provided at the time of application.

The templates are equivalent to similar templates used by comparable overseas regulators and our international collaborators in international regulatory forums.

Bioequivalence study summary template

This form could be used when you are submitting bioequivalence study data.

For guidance on completing this template, see Completing the Bioequivalence Study Information Form.

Biowaiver templates

Additional strength biowaiver template

This template could be used when bioequivalence study data has not been generated for all strength products and you are required to submit biowaiver data for these products.

Note: the additional strength biowaiver template currently is designed for systemically active immediate release oral dosage form.

Biopharmaceutics Classification System (BCS)-based biowaiver template

This template could be used when you are submitting BCS-based biowaiver data for all proposed strength products.

For guidance on completing the biowaiver templates, see Completing the biowaiver templates.

If you submit the BSIF, BCS-based biowaiver template, or an equivalent overseas template, you will not be required to submit:

  • Module 2.5
  • Module 2.7
  • Summary of a bioavailability or bioequivalence study form.

For further details, refer to guidance on Completing the Bioequivalence Study Information Form and Completing the biowaiver templates.

If you have any enquiry about templates, direct your queries to pcsinbox@health.gov.au.